Category: FDA Warnings

Working with others, we strive to alleviate distress and to support and enhance the personal growth, transformation, individuation, self-determination, and clear and expanded awareness of individuals. Necessity dictates that we also spend a lot of time challenging aspects of the mental health profession that do the opposite—creating more distress, suppressing growth and transformation, violating self-determination, and dulling and blinding awareness. We call it psychiatric oppression, the systematic, institutionalized mistreatment of those judged as “mentally ill.” This essay focuses especially on the ever expanding encroachment of psychiatric oppression to more and more of the population, and to individuals who are less and less in need of actual help. This encroachment takes the form of mass marketing for psychiatry and the pharmaceutical industry. One key aspect of oppression theory is the claim to virtue. For psychiatric oppression that claim is the notion that mentally ill people need their treatment; its growing extension is the concept of prevention, that potentially mentally ill people need treatment as well!

The Regressive Progression: Treatment to Prevention

“An ounce of prevention is a pound of cure.” Like all great aphorisms, this one, often associated with Ben Franklin, holds wisdom and is partly true, based on assumption. In this case, one must assume the role of victim of unnecessary malady that necessitates a cure…and that there is a felt connection or empathic relatedness to the one who suffers malady. Where these assumptions are not met, the aphorism is false. To wit, for the giant corporation of Halliburton and its government and military operations group, or for the mercenary army of Blackwater, going to war is worth a great deal more than diplomacy.

Like this:

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Unlike Vogue Magazine or TIME, for some reason ABC has decided to promote more misinformation that will no doubt prove deadly for far too many babies, and possibly mothers too. Read on to find out more…

As I wrote in those articles, I had sent numerous emails to the producer with various studies and analyses including not only the conflicts of interest (the conflicts document was so extensive that it took up about 20 pages or so in Word and I didn’t even look up all the names) among the researchers either writing or cited in the report, but also a comparison of the difference between the ABC article they published, and the actual report issued by the ACOG and APA.

I don’t expect that I’ll be hearing much back from them, but the reason I am writing this is not because I really wanted to be on TV (far from it) but because it just makes me horrified that the media can take something that says there is evidence of harm to babies (to quote the ACOG release, “[T]he use of antidepressant medications during pregnancy have been associated with negative consequences for the newborn…some studies have linked fetal malformations, cardiac defects, pulmonary hypertension, and reduced birth weight to antidepressant use during pregnancy.”) and twist it around by quoting “experts” with fancy titles who are willing to say that “the jury is still out” on whether antidepressants can hurt babies. The proposition is that it’s the depression that causes the birth defects, not the drugs.

The ACOG report clearly says that there is evidence of harm – but unfortunately when you watch the videos put out or read the articles on the ABCnews.com website you won’t know that unless you look further.

Just think about cases in which mothers who lose babies to antidepressants or have babies with severe birth defects linked to antidepressants go on to have more children off of antidepressants, without further problems in the babies. Julie Edgington is one example (out of 5 children, only one baby had problems and it was the one exposed to Paxil, Manie, her 4th), Kelly S., who lost her baby to a Paxil heart defect, is another. I was myself told that I shouldn’t have more kids because I would risk severe PPD. I had nothing of the sort. Toby is one of the healthiest kids I’ve seen. I know I am not the best example because I wasn’t actually depressed during pregnancy (was never depressed except for when I was taking Zoloft while nursing), but it just goes to show that there is no conscience regarding the harm coming to babies from these drugs. I was told to stay on Zoloft if I ever did want to have another baby. I am so thankful that Toby is drug-free and healthy.

I honestly do not know how these people can live with themselves.

A great example of what the public sees if they are not up on the latest information, but just passively receiving news bytes, is the ABC piece that just came out which covers Heather Armstrong’s story and states that there is no convincing proof that antidepressants cause harm to the baby. In it Heather tells ABC that she went off her meds during her last pregnancy but experienced panic attacks, and then later, suicidal thoughts after her baby was born, so she decided to stay on it during this recent pregnancy.

1) Of course when you go off antidepressants you can experience panic attacks or even suicidal thoughts – it’s called withdrawal. Been there, done that. For me the withdrawal was way worse than being on the drug at a stable dose, but once I got off of the drug and had time for it to clear out of my system I felt so much better.

Perhaps Prozac really helped Heather feel better mentally but that does not justify what could have happened to the baby. During her last pregnancy she says that she had panic attacks. I think I’ll take panic attacks over my baby dying. It wasn’t even until after her baby was born that she says she had suicidal thoughts. So, were those a result of a drug withdrawal, or did she have a hormonal imbalance after birth of estrogen or thyroid that so many women have? I can’t claim to know what caused Heather Armstrong’s depression after her birth of her first child, but I can guarantee that it was not a Prozac deficiency and that there are safe treatments available. However it still makes no sense to me why having PPD would lead someone to consciously decide to take drugs during a subsequent pregnancy. If you had PPD before, then by all means if you are going to take drugs for PPD, do so after the baby is born and don’t do it while nursing. The time it takes you to get your placebo effect should be well worth it considering the peace of mind and increased safety for the baby.

In my opinion the reason women do this sort of thing stems from the misinformation fed to them by their doctors or other people in the public doing the off label marketing spin. Off-label marketing, or promoting psychiatric drugs to pregnant women (no psychiatric drug is FDA approved for pregnancy), by the way, is currently illegal, but the drug companies usually find ways to get others to do it for them. That’s more than I can say for Pfizer’s criminal behavior with the illegal marketing of Geodon and Lyrica.

2) Just because Heather Armstrong’s baby was born without complications (and she had an unmedicated birth if I am not mistaken) does not mean that the drugs are safe. Nor does it mean that whatever drug she is feeding her daughter in her breast milk is safe for the baby. I am so thankful that her daughter is ok so far, because no baby deserves to suffer from these drugs and I truly hope that she continues to be ok.

But this does not excuse pushing drugs on the entire country with misleading information from conflicted “researchers.”

Look at these devastating photos and ask yourself if it is really worth it to expose your baby to something that can cause a birth defect like this, when there is no taking back the exposure. I lived through suicidal and homicidal thoughts for four months because of Zoloft and I would not want to live through that again, but I would rather go through it (drug-induced or not) a hundred more times rather than have to live through losing a baby or having a baby born with a severe birth defect.

I enjoy occasionally drinking wine or mixed drinks, but that doesn’t mean that because I feel relaxed while drinking alcohol, that I should drink when pregnant or that I suffer from an alcohol imbalance.

Women deserve to know the truth about what can happen with these drugs. They deserve to get the truth about what is causing their emotional problems (not some sales tactic like attributing it to an unproven, unprovable chemical imbalance) and how to safely deal with them with “alternative” medicine, orthomolecular medicine, proven hormone therapy, counseling, etc. They deserve support and understanding and compassion. They do not deserve to be fed deadly lies. But mostly, their babies deserve for the mothers to know.

ABC quotes doctors who say you cannot separate the health of the child from the health of the pregnant mother. This is an illogical catch phrase that they use in order to try and make us feel guilty for insisting on drug free options because some women obviously already take antidepressants and find it impossible to stop (again, this is caused by horrific withdrawal and the drug companies seem fine with that). Try and think about what this really means. They are saying that the mother’s mental health cannot be ignored during pregnancy because doing so hurts the baby. They are saying depression is more dangerous than drugs to the baby. Aside from the fact that this is clearly untrue, and that antidepressants do not reduce birth defects, but rather, increase them, think about whether you have ever been sad during pregnancy. Does feeling sad during pregnancy or being depressed cause PPHN, cardiac defects, the lack of a forebrain, and stillbirth? Or do toxic drugs with mystery chemicals that dangerously elevate serotonin and affect the organ development of babies cause these problems?

Something most people don’t know is that Fen-phen which was taken off the market for heart and lung-related deaths is actually a serotonergic drug which was a chemical mirror image of an SSRI. As I have said repeatedly and will say again, when you have drugs leading to heart problems and PPH in adults, how could they possibly not hurt babies the same way or worse?

Even after considering the fact that antidepressants actually cause depression and suicide, and work about as well as a placebo, this catch phrase makes about as much sense to me as saying that a mom who is addicted to crack, or drinks 5 coffees a day, or smokes, or is an alcoholic, should be told to keep doing those things if it eases her anxiety or fatigue while pregnant. Or about as much sense as telling women to go take Thalidomide because we’re not really sure that Thalidomide causes problems and it was probably actually the morning sickness causing the birth defects and not the Thalidomide. The jury is still out on whether swallowing RAID or drinking bleach while pregnant is bad for your baby. Perhaps working in a nuclear plant or handling plutonium should be considered safe for pregnant women too.

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Stop lying to women about what are confirmed, known risks.

If the jury were still out, the FDA would not be issuing warnings like:

“Infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

I can only hope that every person responsible for off-label marketing will be held accountable in some way. I am no expert in FDA or criminal law, but when you essentially have money laundering taking place – drug companies giving donations to organizations, who then promote drugs through their own organizations via blogs, press releases, and speeches, it would seem that either the drug companies, or the individuals doing the marketing should be held to account for the off label promotions.

Warnings/Studies Showing Risks Associated with Antidepressants and Pregnant Women or New Mothers:

There is ample evidence to support the risks associated with placing pregnant women or new mothers on antidepressant drugs:

September 7, 2005: The Australian Therapeutic Goods Administration issued an information sheet to health professionals warning that SSRI antidepressant use—especially Paxil—in early pregnancy could cause congenital [defect at birth] heart abnormalities in newborns.[i]

September 27, 2005: The FDA and GlaxoSmithKline issued a warning that pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy, placed their newborns at increased risk of major congenital and cardiovascular [heart] malformations at birth.[ii]

February 9, 2006: The New England Journal of Medicine found that mothers who took SSRI antidepressants in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN). The condition occurs when a newborn’s circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal. Between 10% and 20% of infants with PPHN would die even if they receive treatment.[iii]

March 10, 2006: Based on the New England Journal of Medicine study, Health Canada issued a warning that SSRI antidepressants and other newer antidepressants when taken by pregnant women placed newborns at risk of developing the rare lung condition; persistent pulmonary hypertension or PPHN.[iv]

April 7, 2006: A Canadian study from the University of Ottawa published by the American Journal of Obstetrics and Gynecology, found pregnant women who used SSRI antidepressants were more likely to have premature and low birth weight babies.[v]

June 2006: An Archives of General Psychiatry study found women who take antidepressants during pregnancy at risk of giving birth to children with respiratory problems.[vi]

July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels.[vii]

November 2006: The journal Epidemiology published a study entitled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations.” Researchers did the study from Aarhus University. It found that pregnant women who take SSRI antidepressants are more likely to have babies with birth defects than mothers who don’t take these drugs.[viii]

August 2007: The American Journal of Psychiatry published a study that determined that antidepressant use during pregnancy was associated with premature births.[ix]

September 18, 2007: A study published in the Annals of Internal Medicine of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy.

Moreover, experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.[x]

The Physicians’ Desk Reference (PDR) states: “Like many other drugs, paroxetine [chemical name for the antidepressant Paxil] is secreted in human milk, and caution should be exercised when Paxil…is administered to a nursing woman.”

February 18, 2005: A study conducted at the Ottawa Health Research Institute and published in the British Medical Journal determined that adults taking SSRI antidepressants were more than twice as likely to attempt suicide as patients given placebo.[xi]

June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications,” that there could be an increased risk of suicidal behavior in adults taking antidepressants. It recommended that physicians monitor adults who took antidepressants for suicidal tendencies.[xii]

August 4, 2005: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting evidence supporting an association between SSRI use and “new onset of suicidality” in adults.[xiii]

“Please I beg you to learn more. Learn everything you can while there is time… Drugs, whether legal or illegal, should not be used during these most precious months of creation.”

April 2, 2009 — Christian Delahunty of Utah believes Effexor is to blame for the death of her six-week-old daughter Indiana, who passed away last September. Given the overwhelming evidence on the toxicity of Effexor and other psychotropic drugs for adults, children, and babies, it seems to be the obvious cause. But in the minds of those responsible for pushing Effexor on Christian and similar drugs down the throats of pregnant women across America, it may be “impossible” to prove that’s the case.

With Mommy

It is only with that mindset of denial, or simple ignorance, that anyone could possibly justify pushing for the passage of the federal legislation called “The MOTHERS Act,” that will increase the number of pregnant women and new mothers taking psychotropic drugs.

Following the birth of her son Anaid in 2001, Christian first started taking antidepressants around six months postpartum – but primarily for stress, fatigue, and trouble coping with her mother’s death. Eventually Christian settled on Effexor because it gave her the most energy. She says she felt medication was her only option because nearly everyone in her family, from aunts to her mother, had been on some kind of antidepressant and she believed that she probably suffered from some sort of hereditary chemical deficiency.

Although Christian had three children – Gavin, Ayla and Anaid, she knew her mother would have wanted more grandchildren. In 2004, she added another baby, Jake, to her family. During that pregnancy Christian switched from Effexor to Zoloft, a milder antidepressant, at her doctor’s recommendation, but went back on Effexor after she finished nursing.

In 2007 Christian approached a new family doctor about whether she should switch back to Zoloft because she wanted one more baby. She was taking 300 mg of Effexor XR (extended release). But the doctor told her, “Oh no, you and the baby will be fine. There are no studies that prove that the Effexor is even transferred to the baby in utero or in the breast milk.”

During her last pregnancy, Christian had developed gestational diabetes (a known effect of antidepressants), went into premature labor two months early (another effect of Effexor), and had to be put on bed rest. She delivered baby Indiana a few weeks early, one month before the due date (37 weeks is considered full term and 38-42 is a normal length for a pregnancy).

When Christian found out that the doctors planned to break her water rather than try to stop contractions, she says that she told her husband, “Matt you’ve got to grab me my Effexor.”

The attending doctor abruptly reacted with, “What?!”

This doctor, who worked with Christian’s regular OBGYN, explained to Christian and Matt that he had delivered many Effexor babies and had seen a lot of problems. “It’s not good for the baby and it needed to be stopped in the first trimester,” he said.

Next he called and warned the NICU to get ready because an Effexor baby was coming.

When Indiana was born she had trouble breathing, scored low on her APGARs, and wouldn’t cry. Christian says she was floppy, excessively sleepy and nearly impossible to feed, and states:

“She was just a really sleepy baby and wouldn’t eat. She would eat for maybe ten minutes and fall asleep. To try and nurse her was extremely difficult. In the NICU they would have to shove a bottle into her mouth just to get her to have a little bit. I would have to wake her up to eat because she would go for too long and she was having problems with keeping her food down anyway. I would burp her and she would usually throw up most of what she would eat and I would try the other side.”

Indiana spent a while in the NICU during the hospital stay and had to be on oxygen and have an IV. She was also in and out of the hospital and doctor’s office after they got to go home. Indiana had jaundice and had to be checked for bilirubin levels four different times. She had been losing a lot of weight so she also had to go in for numerous growth checkups.

Christian says she had to work really hard to wake Indiana from a deep sleep for almost every feeding and that she had to wake her up to switch sides. Her excessive sleepiness never improved, even by five weeks of age.

On September 7, 2008 Christian nursed Indiana at 8 am and then put her down for a nap. Christian went back in to wake her up at 10 and found she was not breathing.

Indiana was rushed to Children’s Hospital by paramedics. The staff was finally able to revive her after 45 minutes and she spent the next five days on life support. But it was too late. MRIs showed Indiana’s brain had badly deteriorated and the family had to let her go. She died on September 13 at six weeks of age.

Indiana with Dad

As reported by Vera Sharav, “In April, 2004, the National Toxicology Program – Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) panel issued a Report after examining all the available published evidence about infants exposed to an antidepressant in utero and / or breast fed by mothers taking an antidepressant.”

As if the conclusions of the report were not bad enough, various studies demonstrate that antidepressants double spontaneous abortions and stillbirths and quintuple preterm births. Babies exposed to SSRIs have a six-fold increased risk of persistent pulmonary hypertension (PPHN), a potentially fatal lung problem. Nearly a third of women who take SSRIs have a baby who dies, is premature or underweight, or who has seizures.

It seems that certain sectors of the medical industry aren’t paying attention. From 2004-2008 (through the 2nd quarter only) the FDA MedWatch Adverse Events Reporting Database amassed 647 adverse reaction reports (amounting to 432 babies’ cases, since some reactions are reported by lawyers, doctors and consumers for the same child) for prenatal or neonatal Effexor exposure, including four reports of Sudden Infant Death Syndrome (SIDS). Two Effexor-SIDS cases were specified as a breast milk exposure only, while one was listed as pregnancy exposure. For the other, with a coma followed by SIDS, the timing of exposure was not specified.

There were also 18 intrauterine deaths, 2 neonatal deaths, 2 stillbirths, 51 miscarriages (spontaneous abortions), and numerous other fatal or life-threatening birth defects, for a total of at least 77 deaths from Effexor alone, not counting the prenatal and neonatal deaths caused by the numerous other psychotropic drugs taken by women during pregnancy or breastfeeding over those four years.

Multiply these totals by a factor of between 10 and 100, because the FDA estimates that only 1-10% of adverse reactions are ever reported. (To see the 2004-2008 reports go to http://www.psychdrugdangers.com/MothersAct.html and then select SNRIs, and Venlafaxine from the drug tables.)

The American Academy of Pediatrics publishes and disseminates a long list of drugs that “may be of concern” in breastfed infants. The tables also appear in The Breastfeeding Answer Book (BAB) published by La Leche League (2003), which is given to leaders and subsequently used to counsel nursing mothers when they request information about drugs and breastfeeding.

In these tables, following a list of psychotropic drugs that “may be of concern” but nonetheless are claimed to have “no reported effects,” is a list of “Food and Environmental Agents” that have effects on breastfeeding. On the list are aspartame (NutraSweet) with the warning, “Caution if mother or infant has phenylketonuria” and a “Vegetarian Diet” with the warning, “Signs of B12 deficiency.”

It’s good to warn women about aspartame and diet, but what about drugs that do not have giant warnings plastered on them like NutraSweet does with PKU?

Effexor is not listed anywhere in the AAP drug tables. It seems psychotropic drugs must be incredibly safe in the mind of the Academy because even though numerous patients have nursed babies on the new antidepressants in the last two decades, there are apparently “no reports” of adverse effects on babies for most of them, at least according to the AAP.

“Drugs of Abuse” such as Amphetamine and Cocaine, Heroin and Marijuana are listed in the table with side effects identical to those listed for antidepressants in current warnings. These same side effects are absent from the AAPs tables for prescription psychotropics, with the exception of Prozac and a few antipsychotics.

Prozac must be the only unlucky antidepressant that’s bad for breastfed infants, even though according to Thomas Hale, Ph.D. and kellymom.com (a breastfeeding information site), it’s the only antidepressant that’s “recommended” for pregnancy. Prozac side effects listed in the BAB for nursing infants include colic, irritability, feeding and sleep disorders, and slow weight gain. Although in a 2002 Mothering Magazine article titled “But Is It Safe For My Baby? Medications and Breastfeeding,” Dr. Hale wrote that Prozac had been shown to induce coma in breastfed infants.

According to kellymom.com’s summary of Dr. Hale’s recommendations, “Effexor can also be used in breastfeeding mothers if it is efficacious. It may be effective against hyperactivity.”

However, kellymom.com later implies that Celexa is no safer than Effexor even though it’s an SSRI and therefore supposedly “weaker” because “There have been two cases of excessive somnolence, decreased feeding, and weight loss in breastfed infants,” according to Hale.

Kellymom.com does note that, “Lithium use by the breastfeeding mother is dangerous to the breastfed infant. Valium use by the breastfeeding mother entails a greater risk of infant sedation, and may perhaps increase the risk of SIDS.”

Finally, a “Drug Hierarchy” of Hale’s first to last choice is listed as: Zoloft, Paxil, Celexa, Effexor, and Prozac.

“Dr. Hale concluded his talk by saying that breastfeeding should be supported fully and not interrupted by mom’s needs for medication; and that treatment of postpartum depression can be accomplished relatively safely in breastfeeding mothers. So, in his consideration, moms should continue breastfeeding and should get drug treatment as needed for depression.”

However according to Candace S. Brown, PharmD, BCPP, CFNP, writing for femalepatient.com, “Illet et al studied three cases of breast-feeding women using venlafaxine [Effexor], and reported M/P ratios of up to 4.7.28… Given their high M/P ratios and the limited amount of information available on these antidepressants [venlafaxine, bupropion, trazodone, and nefazodone], they are not recommended in lactating women at this time.”

Milk-to-Plasma Ratio: Medication concentration in milk is frequently compared with the concentration in maternal serum to quantify the extent of passage; this is known as the milk-to-plasma ratio (M/P). In general, compounds that are weakly protein-bound, highly lipid-soluble, weakly basic, and small in molecular size have higher M/P ratios. Ratios greater than 1 indicate that the medication is present in higher concentrations in breast milk than in maternal serum.The higher the M/P ratio, the greater the infant exposure to medication.

Infants’ abilities to absorb, metabolize, and eliminate drugs determine how these drugs will affect them. Compared with adults, infants have a higher gastric pH, causing basic compounds, which remain un-ionized, to have higher absorption rates than do acidic compounds. Infants also have lower levels of albumin, resulting in higher amounts of free/unbound (and therefore active) medication. Liver metabolic enzymes are immature in infants, decreasing the rate of degradation of medication. In addition, neonates’ kidneys have a glomerular filtration rate that is 30% to 40% of that in adults. Finally, the blood-brain barrier in newborns is not fully developed, and central nervous system concentrations of some lipid-soluble compounds may reach levels that are 10 to 30 times those in serum. As a result of all of these factors, medications that reach the serum in neonates, as compared with those that reach the serum of adults or children older than 6 months, are more likely to be active, less likely to be metabolized and excreted, and more likely to cross into the brain.

Given the confusing and contradictory information found with so many varying sources, whether it’s their La Leche League leader or lactation consultant, a magazine article, or even a breastfeeding website, most new mothers will probably ask for a professional opinion from a doctor or pharmacist. Either one should be readily able to offer the following information straight from the Effexor label, which can be found by merely “Googling” Effexor in breastfeeding or pregnancy:

[Effexor during pregnancy in animal studies resulted in a] “decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. Venlafaxine appears to cross the human placenta near term.

In a prospective study pregnancy outcomes of 150 women exposed to venlafaxine during first trimester were compared with the pregnancy outcomes of a group of pregnant women who received selective serotonin reuptake inhibitor antidepressants and a group of women who received nonteratogenic drugs. The majority of the women in the venlafaxine group took 75 mg/day (range 37.5 to 300 mg/day) of venlafaxine immediate release form. Among the 150 women who were exposed to venlafaxine during pregnancy, 125 had live births, 18 had spontaneous abortions and seven had therapeutic abortions; two of the babies had major malformations.

Yet when Christian Delahunty approached her family doctor about switching from Effexor to a different medication when she wanted to have another baby, she was told that there were “no studies” showing that Effexor even gets to the baby during pregnancy or breastfeeding. According to Christian, the maximum dose of extended release Effexor is 225 mg. She was on 300 mg at the start of her pregnancy and throughout Indi’s life.

Perhaps Christian’s OBGYN and family doctor only recently graduated from medical school, or maybe they both had gone on vacation and missed reading emails when the FDA MedWatch and Wyeth issued a warning letter on June 28, 2004, specifically for doctors on the dangers of Effexor in pregnancy and stated in part, “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.”

Today, Christian spends the days coping with the loss of her daughter but says she feels inspired by baby Indi to help others not have to go through the same tragedy. Christian switched to Lexapro after Indiana died because she wanted nothing to do with Effexor, and then started tapering off the drug slowly. Her last dose was four days ago. Already she says, “I am actually starting to feel better because I don’t feel so controlled by a substance… If you don’t take your dose it affects you horribly. This is the first time I’ve been sober in eight years. It makes me want to cry because it did have so much effect on every part of your life. I was just on a rollercoaster ride, that’s what it feels like.”

“I cope by just praying to God, and in my mind having conversations with Indi. I have an incredible support system and I have to believe – and I think one of the biggest things helping me through this – is that I believe this was her purpose. We had to go through what we had to because she needed to make a difference. She needed to help other people realize that this is serious and it is real.”

“I told my OBGYN at my first consultation that I was on Effexor and she didn’t think there was anything wrong with it. Throughout the pregnancy, I had my doubts and my first instinct was that this wasn’t right, but I was being told that it was just fine. The delivering doctor brought up Effexor. After Indi passed away the thought just kept coming back to me and then I started doing my research and found out how dangerous it was. I Googled Effexor baby, Effexor dangers, Effexor and pregnancy… I was so shocked because it was so easy to do that and I should have done that before. Why didn’t the doctors know that? There is so much controversy over it, why don’t the doctors research more into it without taking the rep’s point of view saying it’s just fine?”

When asked what she thinks about The MOTHERS Act, Christian said:

“It puts so many babies at risk for developing so many different problems. And it puts the mother at risk. Postpartum is normal, it’s natural. It’s learning how to cope with your stress and your situation, rather than just taking drugs to forget about it or to mask what’s natural. There are so many people out there who I know are thinking like I thought – you either have family members on antidepressants or you know somebody – it’s just kinda normal, you know we’ll all start taking an antidepressant… Just because it’s prescribed from a doctor it doesn’t make it safe.”

“I trusted my doctor and that mistake – it cost me. It cost my whole entire family. That is why I have to believe that this was Indi’s purpose. Educate yourselves. If the doctors aren’t going to be educated then we need to. We need to take the power back.”

By the way, the March of Dimes, a pharma-funded group that endorses The MOTHERS Act as well as the use of antidepressants during pregnancy, does warn against the use of caffeine in pregnancy due to a risk of miscarriage.

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I recently got in touch with a woman who signed the petition against The MOTHERS Act after reading the comment that she had lost her 6 week old daughter and believes it was Effexor that caused her death. Luckily I was able to find her on Facebook because Care2 doesn’t give me the emails of the people who sign the petition unless I have to verify their identity.

I am working on a story and video about this, but I just can’t finish it today, and I can’t sit here and not scream at the top of my lungs to the world about this little baby.

Christian Delahunty is Indiana’s mom and she was told by her doctor that Effexor doesn’t even pass to the baby during pregnancy or breastfeeding. However when she was induced one month before her due date because of problems with the pregnancy, Christian’s OB called down to the NICU to tell them to be ready because an Effexor baby would be coming.

This is Indiana.

Bath timeWith Mommysweet babySleeping with a butterfly on her headIndiana in a tie dye dressIndiana with DadIndiana's Funeral

Indiana was found not breathing and rushed to the hospital. She was revived and put on life support, but her brain was deteriorating and it was too late for her.

Drug company studies and FDA reports confirm that SIDS, coma, seizures, stillbirth, birth defects, miscarriage (“spontaneous abortion”), and an increase in neonatal deaths are linked to exposure to antidepressants. All you have to do is look at the drug label for Effexor and see the animal studies to understand the effects on babies.

“[T]here was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known.”

c.

See also (a warning about often fatal serotonin syndrome – serotonin being the brain chemical researchers think is involved in SIDS due to its role in regulating breathing and sleep and wake cycles. Serotonin Syndrome is what most likely killed Heath Ledger and we know that these drugs can kill adults and children, and are especially hard on babies who have a hard time metabolizing the drugs and who have immature blood-brain barriers): http://www.fda.gov/CDER/drug/infopage/effexor/default.htm

Also, here is a website where you can look through all the MedWatch Reports for a four year period of 2003-2007 (select Effexor and you find 6 reports of SIDS among the other infant deaths and other reports): http://www.psychdrugdangers.com/MothersAct.html

We know that these reports represent the tip of the iceberg, with the FDA estimating that between 1-10% of actual adverse events being reported.

I can’t imagine how hard this must be for Christian and her family but I am so glad that she reached out and wants to tell Indi’s story. I was telling my husband today how lucky I felt that our kids are safe and healthy. My doctor told me it was safe to breastfeed Isaac on Zoloft and that I could stay on it during pregnancy. There were times when it seemed like Isaac had stopped breathing and I would nudge him to make him start up again. Like many moms out there at the time I thought I didn’t know better than my doctor and that I could trust him.

Please take this as a warning of what could happen if you use antidepressants when you’re pregnant and breastfeeding. Christian says that Indiana was in and out of the hospital after she was born so obviously this was more than just a random case of SIDS. This is just one example of a mom who went on antidepressants after the birth of a previous child for PPD and the loss of a loved one (her mom) and then stayed on them at the recommendation of her doctor. How many others out there are like her?

I know this deserves more time and a much better write-up, but I feel like I can’t keep this off the blog even though Indi’s story is much bigger than just this post. Here’s hoping that this will somehow reach someone else in time to save their baby. I know that is all Christian can hope for and will help Indiana’s purpose to be realized.

You’ll be seeing more about Christian and Indi and their family very soon.

Mothers Tell Harry Reid to Read Up On FDA Antidepressant Warnings
The FDA has issued 25 warnings on antidepressants ranging from the suicide risk to cautions against use during pregnancy

Contact: Amy Philo, amy@uniteforlife.org, 214-705-0169, 817-793-8028

MEDIA ADVISORY, Aug. 4 /Christian Newswire/ — On July 28, the Senate considered Majority Leader Harry Reid’s motion to invoke cloture on a 398-page, $10 billion package dubbed the “Coburn Omnibus.” As reported by the New York Times, Reid stated, “Not a single one of the 35 bills in this package are partisan or controversial,” He went on to remark that anyone voting “no” would have to explain to his or her constituents. “These bills have been passed by the House of Representatives and their respective Senate committees with overwhelming support from Democrats and Republicans.” Section D of the omnibus is The Melanie Blocker Stokes MOTHERS Act, which would institute subjective screening for mental illness in expectant and new mothers and increase the sales for antidepressants and other drugs. It has never even been discussed in the appropriate Senate committee, much less approved overwhelmingly.

Reid neglected to mention The MOTHERS Act during his speeches Monday. Yet in a comment to the Washington Post, he accused the Senators who opposed cloture of voting against mothers suffering from postpartum depression. Perhaps Senator Reid can explain to the American people why he supported a bill that would increase cases of spontaneous abortions and fatal birth defects while causing more mothers to kill themselves or their children. On the floor, Senator Dick Durbin alluded to the bill but stated that Melanie Stokes had killed herself just a few days after giving birth. In fact, in 2001 Melanie Stokes took her life when 3 ½ months postpartum, but only after she was given four successive cocktails of antidepressant, anti-anxiety, and antipsychotic drugs as well as electroshock. The FDA issued the first-ever black box warning for suicide on antidepressant drugs in September, 2004. Numerous media stories have surfaced about objections to The MOTHERS Act and controversy surrounding it. The bill’s lead sponsor Senator Robert Menendez (D-NJ), who accepted more than $300,000 from pharmaceutical donors during the last election cycle, even went so far as to tell a reporter from the New Jersey Record that he considers the opposition “wrong-minded.” At least for now, the “Coburn Omnibus” seems less of a threat. But victims and survivors are left wondering if Senators Reid, Durbin, and Menendez intentionally disregard matters of life and death, or whether these Congressmen are simply ignorant and out of touch.